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Clinical Trials in Turkey / NCT07702903
Active, not recruiting Not applicable

The Effect of a VTE Prevention Care Bundle in Total Hip Arthroplasty Patients

NCT07702903 · tracked via the Priya Life Science Turkey tracker
Sponsor
Murat Erten
Phase
Not applicable
Started
2025-06-17
Last updated
2026-07-14

Condition(s) studied

Venous ThromboembolismTotal Hip Arthroplasty (THA)Deep Vein Thrombosis

Investigational drug(s) / intervention(s)

VTE Prevention Care BundleStandard Routine Care

VTE Prevention Care Bundle: The VTE Prevention Care Bundle is a comprehensive, multi-component nursing intervention designed specifically for patients undergoing hip replacement surgery. It consists of five structured components applied systematically: 1) Face-to-face patient education regarding VTE risks and preventive strategies; 2) Specific in-bed ankle-pumping and range-of-motion exercises; 3) An early and progressive mobilization protocol; 4) Guided daily fluid management; and 5) Continuous monitoring and proper application of mechanical prophylaxis (elastic compression stockings). These components are implemented collectively to synergistically reduce the risk of postoperative venous thromboembolism.

Standard Routine Care: Patients receive standard routine orthopedic nursing care provided by the clinic, including standard physician-prescribed medical prophylaxis and routine mobilization practices, without the specific, structured elements of the VTE Prevention Care Bundle.

Study summary

Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), remains a critical and potentially life-threatening complication following total hip arthroplasty (THA). Despite standard prophylactic measures, the incidence of VTE can be significant, highlighting the need for comprehensive and structured nursing interventions. A "care bundle" approach-a targeted set of evidence-based practices performed collectively and reliably-has been shown to improve patient outcomes and minimize complications in various clinical settings.

This non-randomized controlled clinical trial aims to investigate the effect of a specifically designed VTE Prevention Care Bundle on clinical outcomes in patients recovering from total hip arthroplasty. The central hypothesis is that the systematic implementation of this care bundle will result in optimized clinical parameters, enhanced recovery experiences, and minimized VTE risks compared to standard routine care.

Study Design and Population:

The study utilizes a quasi-experimental, non-randomized controlled design. Participants are adult patients who have undergone total hip arthroplasty. The Autar DVT Risk Assessment Scale is utilized strictly as an objective filtering tool during the patient selection process (inclusion criteria). Participants are systematically assigned to either a control group or an intervention group based on the study protocol phases.

Interventions:

Control Group: Patients receive the standard, routine orthopedic nursing care provided by the hospital, alongside the standard medical prophylaxis prescribed by their attending physicians.

Intervention Group: Patients receive the specialized VTE Prevention Care Bundle. This comprehensive bundle consists of five core components:

Education: Providing verbal and written information to the patient during the preoperative period.

Early Mobilization: Ensuring controlled ambulation and mobilization in the early postoperative period.

Exercise: Instructing and monitoring in-bed ankle-pumping exercises.

Fluid Management: Encouraging adequate hydration and closely monitoring fluid intake.

Mechanical Prophylaxis: Ensuring the correct application and continuous monitoring of elastic compression stockings.

Data Collection and Follow-up Tools:

Data is collected systematically during the inpatient stay and throughout a 90-day post-discharge period using the following tools:

Descriptive Data Form: Records demographic and clinical characteristics (age, BMI, surgical history).

Clinical Follow-up Chart: A researcher-developed form tracking leg circumference, Homan's sign, edema, erythema, vital signs, and International Normalized Ratio (INR) levels.

Comfort Scale After Hip Prosthesis: A 26-item scale used to evaluate the patient's postoperative comfort.

Newcastle Satisfaction with Nursing Care Scale: A 19-item scale evaluating patient satisfaction with the nursing care received.

Likert-Type Fear of Falling Scale: Assesses patients' fear levels during mobilization.

Post-Discharge 90-Day Follow-up Chart: A researcher-developed form utilized to monitor any hospital admissions or readmissions due to suspected VTE symptoms (leg swelling, pain, shortness of breath) during the 3-month follow-up period.

Funding Status:

A grant application for this research project has been submitted to The Scientific and Technological Research Council of Türkiye (TUBITAK) and is currently under evaluation.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients aged 18 years and older. * Scheduled for elective primary total hip replacement surgery. * Conscious, oriented, and able to communicate effectively to complete questionnaires and understand education. * Volunteering to participate in the study and able to provide written informed consent. * Physically capable of participating in early mobilization and bed exercises postoperatively. Exclusion Criteria: * Previous history of Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE). * Known bleeding disorders or coagulation abnormalities (e.g., thrombophilia). * Contraindications to the use of mechanical prophylaxis/compression stockings (e.g., severe peripheral arterial disease, severe skin lesions, or leg ulcers). * Severe cognitive impairment, dementia, or psychiatric disorders that prevent cooperation with the study protocol and care bundle. * Bedridden prior to surgery or having severe neurological/musculoskeletal conditions completely preventing mobilization.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Mardin Training and Research Hospital, Kızıltepe State Hospital Mardin Turkey (Türkiye)

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07702903 on ClinicalTrials.gov ↗ ← All trials in Turkey